A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died
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|ClinicalTrials.gov Identifier: NCT00061438|
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : September 1, 2017
This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems.
It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful.
This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication).
Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis.
It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis.
Approximately 240 patients will take part in this study.
Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Acute Necrotizing||Drug: meropenem||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicentre, Randomised, Double-blind, Placebo-controlled, Study on the Use of Prophylactic Meropenem Therapy in Subjects With Severe Acute Necrotizing Pancreatitis|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061438
|United States, California|
|San Francisco, California, United States|
|United States, Florida|
|Tampa, Florida, United States|
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, Maryland|
|Baltimore, Maryland, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Worcester, Massachusetts, United States|
|United States, New Jersey|
|Newark, New Jersey, United States|
|United States, New York|
|New York, New York, United States|
|United States, Washington|
|Seattle, Washington, United States|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Study Director:||AntiInfection Medical Science Director, MD||AstraZeneca|